Download for immediate release by the drug control authority ministry

FOR IMMEDIATE RELEASE
BY THE DRUG CONTROL AUTHORITY
MINISTRY OF HEALTH MALAYSIA
NEW SAFETY CONCERNS RELATING TO USE OF
ZELMAC (TEGASEROD)
The Drug Control Authority (DCA) is issuing this public statement to
inform patients and health care professionals about new safety concerns
relating to Zelmac (tegaserod maleate). A new safety analysis conducted by
the United States Food and Drug Administration (US FDA) on Zelnorm (the
brand name under which tegaserod is marketed in the US) found a higher
incidence of serious adverse cardiovascular events (e.g. angina, heart attack
and strokes) in patients treated with Zelnorm compared to those treated with
placebo (sugar pill). Zelnorm is being taken off the US market.
In Malaysia, Zelmac is approved for the symptomatic treatment of female
patients with abdominal pain and constipation associated with irritable
bowel syndrome (IBS)
DCA announces the following:
• Novartis Corporation (M) Sdn. Bhd. has suspended importation and
sale of Zelmac with immediate effect
• New patients should not be started on Zelmac
• Patients being treated with Zelmac should contact their doctor to
discuss if alternative treatment is needed for their condition
In the meantime the DCA will monitor the decisions taken by other health
authorities and further assess the situation before taking a final position on
Zelmac’s product registration status.
Zelmac Suspension (2/4/07)